This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).
This Phase 2/3 multicenter, randomized, placebo-controlled, double-blind study will evaluate the safety and efficacy of JZP926 capsule in participants aged ≥ 10 years with Juvenile Myoclonic Epilepsy (JME). The study will assess the efficacy of JZP926 capsule as an adjunctive treatment in reducing the frequency of myoclonic seizure days when compared with placebo, as well as the effect of JZP926 capsule on non-seizure endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
260
Oral administration BID according to body weight
Oral administration BID according to body weight
Banner University Medical Center
Phoenix, Arizona, United States
Yale University
New Haven, Connecticut, United States
Change from baseline in myoclonic seizure days per 28 days (Part A and Part B)
Time frame: Baseline up to end of 16 weeks treatment period
Patient and Caregiver Global Impression of Change in Usual Daily Activities (P/CaGI-C UDA) (Part A and Part B)
Time frame: Week 16
Proportion of participants who achieve ≥ 50% and ≥ 75% reduction from baseline in myoclonic seizure days (Part A and Part B)
Time frame: Baseline up to end of 16 weeks treatment period
Change from baseline in days with any seizure type per 28 days (Part A and Part B)
Time frame: Baseline up to end of 16 weeks treatment period
Number of days with fewer myoclonic seizures than participant average prior to entering the study per 28 days (Part A and Part B)
Time frame: Baseline up to end of 16 weeks treatment period
Percent change from baseline (historical + prospective) in generalized tonic-clonic (GTC) seizure frequency (Part A and Part B)
Time frame: Baseline up to end of 16 weeks treatment period
Number of participants reporting treatment-emergent adverse events (Part A and Part B)
Time frame: Baseline up to end of 16 weeks treatment period
Mean plasma concentration for CBD
Time frame: Baseline up to end of 16 weeks treatment period
Mean plasma concentration of metabolite 7-OH-CBD
Time frame: Baseline up to end of 16 weeks treatment period
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Pediatric Epilepsy & Neurology Specialists
Tampa, Florida, United States
Emory Healthcare
Atlanta, Georgia, United States
Savannah Neurology Specialists
Savannah, Georgia, United States
Hawaii Pacific Neuroscience, LLC
Honolulu, Hawaii, United States
Consultants in Epilepsy and Neurology
Boise, Idaho, United States
Louisiana State University
Baton Rouge, Louisiana, United States
Corewell Health
Grand Rapids, Michigan, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
...and 9 more locations
Mean plasma concentration of metabolite 7-COOH-CBD
Time frame: Baseline up to end of 16 weeks treatment period